NCT00802932

Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Tx

Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 61 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test metallic markers in the breast tissue after breast conserving surgery and to observe the metallic markers' stability in the breast for use as tumor bed markers and positioning devices for radiation treatment.

Detailed description

In order to validate metallic marker placement and stability, patients will have the internal metallic markers placed at the time of their last breast surgery (either lumpectomy or re-excision for margins) by the surgeon and are permanent. They will undergo routine 3D CT-based treatment planning and will receive routine radiation treatment to the whole breast or partial breast as determined by the treating physician. Daily images of the breast will be obtained throughout treatment using the online portal imaging system. These images will be analyzed for the daily position of the metallic markers and compared across the entire course of treatment to determine the stability of metallic markers placement and to assess their efficacy as positioning devices for image guided radiation therapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Non-contrast Computed Tomography (CT) Scans (Metallic Markers)	Non-contrast CT Scans prior to start of radiation therapy, and during weeks 2, 4, 6.
DEVICE	Non-contrast CT Scans (Metallic Markers)	Non-contrast CT Scans prior to start of radiation therapy and on Day 5.

Timeline

• Start date: 2008-03-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2008-12-05
• Last updated: 2013-01-30

Locations

1 site across 1 country: United States